GM-CSF and Rituximab After Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin Lymphoma

Therapuetic Areas:Oncology
Age Range:18 - 70
Start Date:October 2007
End Date:July 2013

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A Phase II Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma

RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant helps
stop the growth of cancer cells by stopping them from dividing or by killing them. An
autologous stem cell transplant may be able to replace the blood-forming cells that were
destroyed by chemotherapy. GM-CSF may increase the number of immune cells found in bone
marrow or peripheral blood. Giving a monoclonal antibody, such as rituximab, after the
transplant may find any remaining cancer cells and either kill them or deliver
cancer-killing substances to them without harming normal cells. Giving GM-CSF together with
rituximab after autologous stem cell transplant may be an effective treatment for follicular
non-Hodgkin lymphoma.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab
after autologous stem cell transplant works in treating patients with relapsed or primary
refractory follicular non-Hodgkin lymphoma.



- To assess the progression-free survival rate at 2 years after autologous stem cell
transplantation (ASCT) in patients with relapsed or primary refractory follicular
lymphoma treated with sargramostim (GM-CSF) and rituximab after ASCT.


- To assess the safety of administering GM-CSF and rituximab after ASCT.

- To assess the effects of GM-CSF on the relative expression of activating and inhibitory
FcγR on circulating monocytes.

- To assess the effects of GM-CSF on the relative expression of activating and inhibitory
FcγR on circulating dendritic cells.

- To assess the effects of GM-CSF on the level of circulating FcγR.

- To assess the reconstitution of NK cells, NK-T cells, dendritic cell subsets, and
regulatory T-cells after ASCT.


- High-dose chemotherapy: Patients receive carmustine IV over 2 hours on day -7,
etoposide IV over 1 hour and cytarabine IV every 12 hours on days -6 to -3, and
melphalan IV on day -2.

- Autologous stem cell transplantation (ASCT): Patients undergo ASCT on day 0. Patients
receive filgrastim (G-CSF) subcutaneously (SC) once a day beginning on day 5 and
continuing until blood counts recover.

- Sargramostim (GM-CSF) and rituximab: Beginning approximately 7-10 weeks (49-70 days)
after ASCT, patients receive GM-CSF SC 3 times a week for 8 weeks and rituximab IV once
weekly for 4 weeks (beginning within 3 days after the first dose of GM-CSF). Patients
receive a second course of GM-CSF and rituximab (as above) beginning approximately
22-26 weeks (154-182 days) after ASCT.

After the completion of study treatment, patients are followed periodically for 2 years.


- Histologic diagnosis of grade 1, 2, 3, or transformed follicular lymphoma

- Achieved a complete or partial response to last salvage therapy

- Completed salvage therapy within the past 12 weeks

- No disease progression since last salvage therapy

- One of the following disease statuses must have been present prior to receiving
salvage therapy

- Refractory to last anti-lymphoma therapy

- Last remission duration less than 1½ years if salvage therapy is 3rd regimen

- Last remission duration less than 3 years if salvage therapy is 2nd regimen

- Minimum of 2 x 10^6 CD34+ cells/kg cryopreserved and available for hematopoietic stem
cell support

- No leptomeningeal disease or brain parenchyma involvement


- Cardiac ejection fraction > 50%

- If over 60 years of age, no evidence of cardiac ischemia by treadmill stress
test (stress echo or sesta-MIBI)

- Adjusted diffusing capacity ≥ 50% of the predicted value on pulmonary function

- Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 50 mL/min

- ANC > 1,000/μL

- Platelet count > 50,000/μL

- Total bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL if Gilbert's disease is suspected)

- Not pregnant or breast-feeding

- Fertile patients must use an acceptable form of birth control

- HIV I or II negative

- No acute or chronic hepatitis B

- No active hepatitis C

- No medical illness (unrelated to non-Hodgkin lymphoma), including malignancies that,
in the opinion of the attending physician and/or principal investigator, would
preclude study treatment

- No other malignancy within the past 5 years except curatively treated cutaneous basal
cell or squamous cell carcinoma or carcinoma in situ of the cervix


- No more than 3 prior anti-lymphoma regimens, inclusive of the salvage therapy

- Biologic agents (e.g., monoclonal antibodies and vaccines) administered as part
of a planned treatment regimen will not be considered distinct regimens

- Chemotherapy administered primarily for the purpose of stem cell mobilization
(e.g., cyclophosphamide at 2-4 g/m²) will not be considered an anti-lymphoma

- No prior autologous or allogeneic hematopoietic stem cell transplantation
We found this trial at
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
New York, NY
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